SUMMARY:
Lithion Battery is a vertically integrated manufacturer of cells and rechargeable battery packs servicing the Medical, Energy, Robotics, Industrial, and Military/Defense markets. Lithion Battery works closely with OEM manufacturers and end users to provide custom and high-quality power solutions for critical applications where reliability is paramount.
At Lithion Battery Inc. the job of a Quality Engineer is to develop, manage, maintain, and improve processes & databases for product compliance. Requirements for compliance include all sourced components/products, meeting customer specifications, compliant to regulatory directives and quality standards. They will support the planning, coordination, and execution of assigned deliverables.
Focuses on sustainability of Quality Management System, product compliance and improvement. Supporting the Quality and the production team to implement methods to inspect, test and evaluate products and production equipment.
DIRECT REPORTS:
KEY RESPONSIBILITIES:
- Create and maintain work instructions, standard operating procedures (SOPs), control plans, PFMEAs and train the production team in best practices and quality inspection techniques.
- Support the PPAP process for new product and process introductions, ensuring all necessary documentation, validations and approvals are in place for start of production.
- Lead investigations using problem-solving methodologies to identify root causes and implement corrective actions for quality issues such as, and not limited to: 8D problem-solving, Fishbone, FOG Analysis, 3 Legged 5 Whys and Pareto Analysis.
- Work with suppliers to provide detailed reports of part issues, including utilizing SCARs (Supplier Corrective Action Requests) to address non-conformances, investigate root causes, and ensure corrective actions are taken.
- Develop and perform incoming, calibration, line validations, and process audits to ensure compliance with product specifications, quality standards, and regulatory requirements.
- Identify areas for improvement and collaborate with cross-functional teams to implement continuous improvement initiatives.
- Monitor and manage deviations from standard processes, reviewing, documenting, and ensuring corrective and preventive actions are taken. Evaluate and approve process changes, ensuring they meet product specifications and regulatory requirements.
- Prepare comprehensive reports by collecting, analyzing, and summarizing data on quality metrics, product performance, and compliance audits, ensuring the information is clear and actionable for management.
- Communicate findings to management, providing actionable insights and recommendations for improving processes, reducing defects, and meeting quality goals.
- Lead/facilitate review and disposition of discrepant materials identified for control of nonconforming product through Material Review Boards (MRB)
- Perform other duties as required, including any additional tasks needed to maintain quality standards and ensure the continuous improvement of processes.
QUALIFICATIONS & KEY COMPENTENCIES:
- 2 to 4 years previous experience in a manufacturing environment
- Skilled in measurement and visual inspection techniques
- Skilled in statistical data analysis and pivot charts
- Familiar with ISO 9001 standards, practices, and procedures.
- Strong Microsoft Office application skills, including Excel, Word, and PowerPoint.
- Self-motivated, with strong organizational skills and the ability to prioritize tasks in a demanding environment with high attention to detail.
- Ability to work under pressure and achieve deadlines.
- Ability to follow policies and procedures.
Preferred but not Required:
- Validation Knowledge for IQ, OQ and PQ complying to ISO 9001
- Auditing experience or certification to ISO 9001
- Manufacturing Knowledge for Battery cells